Get Cms 116

This guide provides step-by-step instructions for completing the Cms 116 form, an essential application for certification under the Clinical Laboratory Improvement Amendments (CLIA). Whether you are making an initial application or changing your laboratory's certificate type, this guide will help you navigate the process with confidence and clarity.

Follow the steps to complete the Cms 116 seamlessly.

1. Press the ‘Get Form’ button to access the form and open it for editing.
2. Complete Section I which includes general information about your facility. This includes selecting the type of application (initial application, survey, or change in certificate type), and entering your facility name and CLIA identification number if available.
3. Provide your facility's physical and mailing addresses, including a valid email and phone number to ensure you can receive important updates.
4. In Section II, select the type of certificate requested based on the complexity of the tests performed by your laboratory. This includes options like Certificate of Waiver or Certificate of Compliance.
5. In Section III, indicate the type of laboratory you operate by selecting an option from the provided list, such as hospital, independent facility, or mobile laboratory.
6. Fill out Section IV by providing the hours during which laboratory testing is performed. If your laboratory operates 24/7, check the appropriate box.
7. If applicable, complete Section V regarding multiple sites to indicate if you are applying for a single CLIA certificate to cover multiple testing locations.
8. Sections VI, VII, and VIII require you to identify the tests performed by your laboratory, detailing the annual test volume for waived, PPM, and non-waived testing.
9. In Section IX, select the type of ownership that best describes your laboratory.
10. Finally, ensure all fields are completed accurately and legibly before signing and dating the application in Section X. Note that submissions must be sent to your local State Agency, and no payment should accompany the completed application.
11. Once completed, you can save the changes, download, print, or share the Cms 116 form as needed.

Start filling out your Cms 116 form online today to ensure your laboratory meets all necessary certification requirements.